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RESPONSE TO NEWS PUBLISHED BY THE DANISH MEDICOINDUSTRIEN

Please be aware that a ”breaking news” has been released from “Medicoindustrien” (a national association within MedTech Europe) informing that Presafe Denmark A/S will close, that all certification activities will be moved to Presafe headquarter in Norway and that this will lead to a change of the ID number for all devices carrying the Presafe Denmark A/S ID number (CE0543).

Presafe Denmark A/S would like to clarify the information given in the “breaking news”.- Presafe Denmark A/S remains to be a Notified body within the Medical device directive and the In-vitro diagnostic directive, and a registrar for ISO 13485 and ISO 9001- Presafe Denmark A/S continues to work out of the office in Hellerup, Denmark- There are no changes to the organization, to auditors, to assessors etc.Thus Presafe Denmark A/S will continue to work as a notified body and thus the certification as per the MDD/IVDD can continue.

“Future” Medical device regulation (MDR) and the In-vitro diagnostic device regulation (IVDR).Presafe Denmark A/S and DNV GL Nemko Presafe A/S has decided to apply for the designations in Norway and not in Denmark.The decision has been taken as the benefits for Presafe, as well as customers, in being one notified body exceeds those of being 2 notified bodies. The benefits include- Access to a larger pool of resourceso Access to >150 auditors/assessors worldwideo Less vulnerability with respect to specific competences in the organizationo Possibility of local auditors- Identical processes in Denmark and Norway- Maintenance of one quality system and one notificationIn addition, it is realized that the activities and resources needed over the next years to ensure that we can certify customers to MDSAP (in collaboration with SAI Global) as well as the MDR/IVDR will require that we minimize administrative work and have the possibility of using resources from Presafe in Norway.Presafe Denmark A/S will continue to be a main part of the Presafe organization and we will continue to serve customers out of the Danish organization.

All customers will be contacted within the next weeks with further information on the change as well as information on how to transition from the current MDD/IVDD certification to the MDR/IVDR certification.

We realize that the information will raise a range of questions - Should you have any immediate questions or need clarification, please feel free to contact us at presafedk@presafe.com or +45 3945 4999